Methods and devices for crimping self-expanding devices

ABSTRACT

Described here are devices and methods for crimping self-expanding devices. The crimping devices may be useful for crimping a variety of different self-expanding devices (whether such devices are biodegradable or bio-durable). The crimping devices may have crimping members to engage the self-expanding device to reduce the device from an expanding configuration to an unexpanded configuration. The crimping member may comprise or include a suture, wire, ribbon, guiding hoop, pusher, prong, holding bar, balloon, jaws, combinations thereof, or the like. The crimping devices may also include or comprise a holding structure to hold the self-expanding device in an unexpanded or expanded configuration.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 12/512,855, filed Jul. 30, 2009, now issued as U.S. Pat. No.8,763,222, which claims priority to U.S. Provisional Application Ser.No. 61/085,795, filed Aug. 1, 2008, the entirety of each of which ishereby incorporated by reference in its entirety.

FIELD

The present invention relates generally to methods and devices forcrimping self-expanding devices.

BACKGROUND OF THE INVENTION

There is a movement toward using minimally invasive approaches fortreating conditions or diseases. Because they can be delivered in anunexpanded configuration, self-expanding devices may be useful toprovide a minimally invasive way to maintain, open, or dilate bodilystructures such as veins, arteries, ureters, urethras, hollow-bodyorgans, nasal passages, sinus cavities, and the like. Theseself-expanding devices may serve a number of therapeutic functions, andmay be used to release one or more drugs to a target location.Furthermore, self-expanding devices may be designed to degrade overtime. For example, self-expanding devices may be used to provideanatomical support to one or more sinus openings or ostia followingfunctional endoscopic sinus surgery.

In order to provide a self-expanding device to an anatomical location,generally it first must be reduced to an unexpanded configuration. Theremay be problems, however, with crimping a self-expanding device to anunexpanded configuration. These problems may arise from the geometry ofthe self-expanding device, from maintaining the sterility of the device,or from a number of other sources. Thus it may be useful to providedevices to crimp a self-expanding device to an unexpanded configuration.

BRIEF SUMMARY OF THE INVENTION

Described here are devices and methods for crimping self-expandingdevices. The crimping devices described here may be useful for crimpinga variety of different self-expanding devices. In some variations, theself-expanding device is biodegradable. In other variations, theself-expanding device is bio-durable. The self-expanding device maycomprise, incorporate, or deliver one or more drugs or active agents,and the crimping device may be configured to be compatible with suchdrug or active agent so as not to destroy or limit its efficacy. In somevariations, the devices described here have one or more crimpingmembers. Generally, a crimping member is a structure that may engage aself-expanding device to reduce the self-expanding device to anunexpanded configuration from an expanded configuration. In somevariations, the crimping members comprise a suture, wire, ribbon,guiding hoop, pusher, prong, holding bar, balloon, jaws, a combinationthereof, or the like. Any crimping member, or combination of crimpingmembers, may be used, as appropriate, with any of the crimping devicesdescribed here. Additionally, any crimping member may include one ormore handles.

In some variations, crimping devices are described here having acrimping member, where the crimping member engages the self-expandingdevice to reduce the self-expanding device to an unexpandedconfiguration from an expanded configuration, and where the crimpingdevice engages an applicator or storage member to hold theself-expanding device in its unexpanded configuration. The crimpingdevices described here may additionally include one or more holdingstructures configured to hold one or more self-expanding devices intheir expanded configurations, or in some instances, their un-expandedconfigurations. The holding structure may define an aperture, but neednot. The holding structure may be or comprise a hoop, canister, cage,plate, funnel, rod, sheath, wire, ribbon, ring, a combination thereof,or the like. The holding structure may be made of a single continuouscomponent, or may be made of two or more separate components.Additionally, each component of the holding structure may be made of onematerial, or may be made from a combination of materials.

In some variations, the holding structure may include one or morepassage units. Generally, passage units provide a structure throughwhich a crimping member may pass into or out of a holding structure.Examples of suitable passage units include, but are not limited to,slits, slots, holes, grooves, contours, pulleys, and rollers.Additionally, the holding structure may include one or more tracks. Whena holding structure includes one or more tracks, it may additionallyinclude one or more pins that are slidably disposed in one or more ofthe one or more tracks.

In other variations of the devices described here, the crimping devicesmay have a holding structure, where the holding structure is configuredto hold therein the self-expanding device in an expanded configuration,and a crimping control, where movement of the crimping control relativeto the holding structure causes the crimping device to reduce theself-expanding device to an unexpanded configuration. In somevariations, the crimping control rotates relative to the holdingstructure. The holding structure may be any holding structure, orcombination of holding structures, and may include any feature orcombination of features as described above. Additionally, the crimpingcontrol may include tracks. In variations in which both the holdingstructure and the crimping control include tracks, the crimping devicemay include pins that may be slidably disposed within the tracks of boththe crimping control and the holding structure. In some of thesevariations, the tracks of the holding structure project radially from acenter of the holding structure, and the tracks of the crimping controlcurve radially away from a center of the crimping control. In somevariations, the crimping device includes one or more crimping members.The one or more crimping member may be any suitable crimping member orcombination of crimping members as described above. In some of thesevariations, the crimping control engages one or more of the one or morecrimping members.

In still other variations of the crimping devices described here, thecrimping devices have a crimping portion where the crimping portion hasa first end, a second end, an interior surface and a plurality of slitsrunning between the first and second ends, where the cross-sectionalarea of the crimping portion decreases from the second end to the firstend, and where the interior surface of the crimping portion isconfigured to house the self-expanding device in an expandedconfiguration. These variations may also include a pusher, where thepusher includes a plurality of prongs that engage one or more of theplurality of slits and where movement of the pusher from the second endof the crimping portion toward the first end of the frame compresses theself-expanding device into an unexpanded configuration. Additionally,the crimping portion may define an aperture through which theself-expanding device may be retrieved. In some variations, the crimpingdevice may include a storage zone that is configured to releasably holdthe self-expanding device in an unexpanded configuration. In othervariations, the crimping device may be configured for attachment to anapplicator for delivery of the self-expanding device to a targetlocation. The crimping device may or may not be integral with, orpermanently connected or coupled to a delivery applicator.

Other variations of the crimping devices described here have a firstplate and a second plate, where the first plate and second plate areslidably engagable to define an aperture and where the aperture has across-sectional area that changes when the first plate is slid relativeto the second plate. In some variations, the crimping device may includea third plate. This third plate may be fixedly attached to one or moreof the other plates, or may be slidably engagable with one ore more theother plates. Additionally, the aperture defined by the plates may havea substantially symmetrical shape, but need not. In some variations, theaperture has a substantially diamond shape.

Still other variations of crimping devices are described here having acrimping portion that may be configured to reduce the self-expandingdevice from an expanded configuration to an unexpanded configuration, astorage zone that may be configured to house the self-expanding devicein its unexpanded configuration, and an applicator engagement portionthat may be configured to engage a distal end of an applicator. In somevariations, the crimping device may have one or more blades or cuttingstructures. In other variations, the crimping device may include afunnel.

Also described here are methods for crimping a self-expanding device.Generally, any of the devices described here may be used to crimp aself-expanding device. Furthermore, any of the methods described heremay be used to crimp any suitable self-expanding device, such as abiodegradable self-expanding device. In some methods, a self-expandingdevice may be crimped directly into the interior of a delivery device orstorage member using a crimping device. In some of these methods, thecrimping device is integral with the delivery device or storage member.In some of these methods, the crimping device may have a funnel. Inother methods, the crimping device may have one or more crimpingmembers. In still other methods the crimping device may define anaperture.

In other variations of the methods described here, a self-expandingdevice may be crimped using a crimping device and may be retrieved fromthe crimping device via a delivery device. In other variations, thecrimped self-expanding device may be retrieved through an aperturedefined by the crimping device. In some methods, the crimping device mayinclude one or more connection members. Examples of suitable connectionmembers include, but are not limited to sutures, ribbons, guiding hoops,pushers, balloons, combinations thereof, and the like. In other methods,the crimping device has one or more handles. In still other methods thecrimping device may include a holding structure such as a hoop, or mayinclude one or more passage units.

Still other methods for crimping a self-expanding device are describedhere comprising crimping a self-expanding device to an unexpandedconfiguration using a crimping device and maintaining the self-expandingdevice in its unexpanded configuration using a water-soluble component.

Also described here are methods of using a self-expanding device.Generally these methods comprise storing the self-expanding device inits expanded configuration, crimping the self-expanding device to itsunexpanded configuration immediately prior to use, and delivering theself-expanding device at an anatomical location. These methods may beutilized for biodegradable self-expanding devices. In some of thesemethods, the expanded self-expanding device is stored in a protectivecontainer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-5 are illustrative depictions of suitable variations of crimpingdevices having one or more crimping members and one or more handles.

FIGS. 6A-6D depict an illustrative method of crimping a self-expandingdevice using a suitable variation of the crimping devices describedhere.

FIGS. 7A-7D are illustrative depictions of a suitable crimping devicehaving a holding structure and a crimping member. FIGS. 7A and 7B areperspective views showing the crimping device engaging a self-expandingdevice in an expanded configuration and an unexpanded configuration,respectively. FIGS. 7C and 7D are top views showing the crimping deviceengaging a self-expanding device in an expanded configuration and anunexpanded configuration, respectively.

FIGS. 8-9 are illustrative depictions of suitable variations of holdingstructures.

FIGS. 10A-10C depict an illustrative variation of a crimping devicehaving a holding structure and a crimping member. FIG. 10A is aperspective view of the entire crimping device. FIGS. 10B and 10C arecutaway views of the interior of the crimping device of FIG. 10A.

FIG. 11 is an illustrative depiction of a suitable variation of acrimping device having one or more crimping controls.

FIGS. 12A-12D show another variation of a crimping device having one ormore crimping controls. FIG. 12A is a perspective view of the crimpingcontrol. FIG. 12B is a perspective view of the entire crimping deviceand FIGS. 12C and 12D are bottom views of the crimping device of FIG.12B.

FIGS. 13-17 depict illustrative variations of additional features thatmay be included in any of the crimping devices described here.

FIGS. 18A-22B depict illustrative variations of suitable crimpingdevices described here, having crimping portions.

FIGS. 23A-24B depict illustrative variations of suitable crimpingdevices described here having two or more plates.

FIGS. 25-28D are illustrative depictions of suitable variations ofcrimping devices having one or more crimping members and one or morehandles.

FIGS. 29A-29E depict an illustrative variation of a crimping devicehaving one or more crimping members.

FIGS. 30A-33 depict illustrative variations of additional features thatmay be included in any of the crimping device described here.

FIGS. 34A-34C show another variation of a crimping device having one ormore crimping controls.

FIGS. 35A and 35B are illustrative depictions of suitable crimpingdevices having crimping portions.

FIGS. 36A-38F show illustrative depictions of suitable variations ofcrimping devices having crimping tubes.

FIGS. 39 and 40 depict illustrative variations of crimping devices thatmay crimp multiple self-expanding devices.

DETAILED DESCRIPTION OF THE INVENTION

Described here are devices for crimping a self-expanding device into anunexpanded configuration. Methods for crimping self-expanding devicesare also described here. This self-expanding device may bebiodegradable, but need not be. For example, the self-expanding devicesmay be bio-durable, or made of one or more bio-durable components (e.g.,metals, biod-durable polymers, etc.). Furthermore, the devices andmethods described here may be utilized to reduce self-expanding devicesof a variety of shapes and configurations. For example, theself-expanding device may have a tubular structure, such as a coil. Theself-expanding device may have a crown shape, or a substantiallyrepeating diamond pattern. The crimping devices and methods describedhere may find particular utility with the self-expanding devicesdescribed in application No. 61/058,803, which is hereby incorporated byreference herein in its entirety. Additionally, the crimping devicesdescribed here may be configured to crimp multiple self-expandingdevices.

Methods for crimping a self-expanding device generally involve using oneof the devices described here to engage and reduce a self-expandingdevice from an expanded configuration to an unexpanded configuration. Insome variations, the crimped self-expanding device is then transferredinto a storage member, applicator or other device. In some methods, theself-expanding device may be crimped directly into a storage member,applicator, or other device. In other methods, the self-expanding devicemay be removed from the crimping device using a storage member,applicator, or other device (e.g., through one or more apertures or thelike). In still other methods, an additional device may be used to movethe crimped self-expanding device from the crimping device to a storagemember, applicator, or other device. In some methods, part or all of thecrimping device is disengaged from the self-expanding device followingcrimping.

In some instances, it may be desirable to maintain a self-expandingdevice in an expanded configuration until a time immediately prior todelivery (e.g., minutes, hours, or days). As such, in some methods, aself-expanding device may be stored in an expanded configuration. Insome of these methods, the self-expanding device may be stored in and/oron a protective container. When a self-expanding device is going to bedelivered to an anatomical location, the self-expanding device may becrimped at the site of the delivery procedure, and may be crimped priorto its delivery at the anatomical location. Because the crimping devicesdescribed here may be used to crimp a self-expanding device during asterile procedure, it may be desirable for the crimping devicesdescribed here to be sterilizable.

Some of the crimping devices described here comprise one or morecrimping members. In some of these variations, the crimping devices mayadditionally contain one or more handles, but need not. FIG. 1 shows onesuitable variation of crimping device (100), comprising crimping member(102) and handles (104), engaging self-expanding device (106) comprisingloops (108). While shown in FIG. 1 as being a suture, crimping member(102) may have any suitable configuration. Generally, crimping membersare configured to engage a self-expanding device to reduce theself-expanding device to an unexpanded configuration. Examples ofsuitable crimping members include, but are not limited to, sutures,wires, ribbons, guiding hoops, pushers, prongs, holding bars, jaws,balloons, combinations thereof, and the like.

A crimping member may additionally include one or more structures to aidin engagement between the crimping member and the self-expanding device.For example, FIG. 25 shows one variation of device (2500) comprisinghandles (2509) and crimping member (2502) with ring (2504) and hooks(2506), and engaging self-expanding device (2508). Crimping member(2502) may have any combination of hooks (2506) and rings (2504). Forexample, crimping member may comprise zero, one, or two or more hooks(2506) and zero, one, or two or more rings (2504). Generally, hooks(2506) and rings (2504) may be placed around or through any suitableportion of self-expanding device (2508). In variations, in whichself-expanding device (2508) comprises loops (2510), hooks (2506) orrings (2504) may engage one or more of these loops (2510). Althoughshown in FIG. 25 as being slidably disposed along crimping members(2502), rings (2504) and hooks (2506) need not be. Indeed, rings (2504)and hooks (2506) may be fixedly attached to crimping members (2502). Insome variations, some of the rings (2504) and hooks (2506) may beslidably disposed along crimping members (2502) while others may befixedly attached to crimping members (2502).

In other variations, the crimping member may include a sheath (e.g. aflexible sheath, a collapsible sheath, a sleeve, a netting or a mesh).FIG. 2 shows one such variation of crimping device (200), comprisingcrimping member (202), first handle (204), second handle (206), andsheath (208). This sheath (208) may aid in engagement with aself-expanding device (not shown) by increasing the surface area contactbetween crimping member (202) and the self-expanding device. In somevariations, a crimping member may comprise a netting or mesh that mayenclose a self-expanding device. For example, FIGS. 26A and 26B show onevariation of crimping device (2600) comprising crimping member (2602)having netting (2604) and handles (2606). A self-expanding device (notshown), may be placed within netting (2604). As handles (2606) arepulled away from each other, netting (2604) is stretched in a horizontaldirection, as indicated by first arrows (2608), which causes the widthof the netting (2604) to be reduced, as indicated by second arrows(2610). This may, in turn, crimp a self-expanding device.

The crimping devices described here may have any number of crimpingmembers. In some variations, the crimping device may have two or morecrimping members. FIG. 3 shows one such variation of crimping device(300), comprising first crimping member (302), second crimping member(304), sheath (306), first handle (308), second handle (310) includingpusher (312), and storage member (314).

In variations where the crimping device comprises handles, the crimpingdevice may have any number of handles. Indeed, the crimping device mayhave three or more handles, two handles, one handle, or no handles.Furthermore, handles may have any shape or configuration, but need nothave the same shape or configuration. In some variations, the handle isconfigured to attach to one end of one crimping member. In othervariations, such as those shown in FIG. 3, the handle is configured toattach to two or more ends of crimping members. In some of thesevariations, the handle may attach to two or more ends of the samecrimping member. In other variations, the handle may attach to one ormore ends of two or more different crimping members. In still othervariations, the handle is configured such that one or more ends of oneor more crimping members may pass through the handle, such as the secondhandle (206) in FIG. 2. In some of these variations, the handle may beconfigured to both attach to one or more ends of one or more crimpingmembers and allow one or more ends of one or more crimping members topass therethrough. This may allow a user to pull a crimping memberthrough a handle while keeping the other end of the crimping memberstationary relative to the handle.

Additionally, a handle may have one or more additional features that maybe useful in the operation of the crimping device. In some variationsthe handle may comprise a pusher, such as the second handle (310) inFIG. 3. This pusher may serve a number of functions. In variations inwhich the crimping device includes a storage member, as described inmore detail below, the pusher may be used to eject a crimpedself-expanding device from the storage member. Additionally, the pushermay be used to hold a storage member when the storage member is notengaging a self-expanding device.

In other variations, the handle may include a structure that allows thecrimping device to engage or attach to a storage member, applicator, orother device. FIG. 4 shows one such variation of crimping device (400),comprising crimping member (402), first handle (404) and second handle(406) having applicator guide (408). In the variations shown in FIG. 4,applicator guide (408) may be placed over the distal end of a storagemember, applicator or other device (not shown). In other variations,applicator guide (408) may fit within, clip onto, or otherwise engage astorage member, applicator, or other device. Furthermore, while shown inFIG. 4 as being a cylindrical structure, applicator guide (408) may haveany configuration that is capable of positioning a storage member,applicator or other device relative to a self-expanding device (notshown). In some variations, applicator guide may be a partial-cylinder,cone, funnel, clip, clamp, or combination thereof. Furthermore,applicator guide may have a non-circular cross-section, which may bedetermined by or based upon the size and shape of the applicator,storage member, or other device.

In some variations, the crimping device may include a storage member,which may, for example, hold a self-expanding device in an unexpandedconfiguration. FIG. 3 illustrates one variation of storage member (314).While shown in FIG. 3 as being a cylinder with a flaring end, storagemember (314) may have any suitable configuration. The shape, dimensionsand configuration of storage member (314) may be dependent on the shapeof the crimped self-expanding device, or may be designed to hold theself-expanding device in a certain way. For example, storage member(314) may be a cylinder, a partial cylinder, a cone, a frustoconicalshape, a box, a sphere, or a combination thereof. Furthermore, thestorage member (314) may have any cross-sectional shape, including, butnot limited to, ovals, circles, rectangles, diamonds, other polygons orshapes with irregular geometries. In some variations, the storage membermay be advanced over one or more crimping members to hold aself-expanding device in an unexpanded configuration. In othervariations, the storage member may be capable of attaching directly to aself-expanding device. For example, the storage member may include aclasp or clip that is capable of attaching around a crimpedself-expanding device.

In some variations, the storage member may be configured to be used asan applicator to deliver a crimped self-expanding device to ananatomical location. In other variations, the storage member may beconfigured to attach to one or more storage members, applicators, orother devices. One or more portions of any suitable crimping devicedescribed here may be configured to be used as an applicator to delivera crimped self-expanding device to an anatomical location, or may beconfigured to attach to one or more storage members, applicators, orother devices to deliver a crimped self-expanding device to ananatomical location.

As described hereinthroughout, the crimping devices described here mayengage a self-expanding device in a number of different ways. Thisengagement may depend on the shape, structure, or configuration of theself-expanding device, but may depend on other factors as well. In somevariations, such as those shown in FIGS. 2-4, one or more crimpingmembers wrap around the outside of the self-expanding device. Invariations in which the crimping member contains hooks or rings, thesehooks or rings may be attached to portions of the self-expanding device.In other variations, one or more crimping members are wound aroundportions of the self-expanding device. For example, FIG. 5 shows onesuch variation of crimping device (500) comprising crimping member (502)and handles (504), and engaging self-expanding device (506) having asubstantially repeating diamond pattern comprising junctions (508). Asshown in FIG. 5, crimping device may be wound around the junctions (508)of self-expanding device (506). While shown in FIG. 5 as being woundaround every junction (508), crimping member (502) need not be. Indeed,crimping member (502) may be wound around all, some, or none of thejunctions (508). Additionally, the crimping member may be wound aroundone or more different portions of the self-expanding device.

In variations in which the self-expanding device has one or more loops,the crimping device may be threaded through one or more of these loops.For example, crimping member (102) of crimping device (100) shown inFIG. 1 is threaded through loops (108) of self-expanding device (106).While shown in FIG. 1 as being threaded through each loop (108),crimping member (102) need not be. Indeed, the crimping member (102) maybe threaded through all, some, or none of the loops (108).

It should be appreciated that a crimping device may engage aself-expanding device in any of the ways or combinations of the waysdescribed above, as well as include any feature or combination offeatures described herein. Furthermore, in crimping devices that containtwo or more crimping members, each crimping member may engage aself-expanding device in the same manner or in different manners.

Any of the devices described above may be used to crimp a self-expandingdevice from an expanded configuration to an unexpanded configuration.FIGS. 6A-6D illustrate one method of crimping a self-expanding device(600) having loops (602) using crimping device (604) having crimpingmembers (606), first handle (608), second handle (610) comprising pusher(612), and storage member (614). Initially, the crimping device (604)may engage self-expanding device (600), as shown in a perspective viewin FIG. 6A and in a side view in FIG. 6B. While shown in FIGS. 6A-6D ashaving crimping member (606) threaded through loops (602), the crimpingdevice (604) may engage self-expanding device (600) in any suitablemanner as described above. Generally, the first (608) and second (610)handles may be pulled away from each other to reduce self-expandingdevice (600) to an unexpanded configuration, as shown in FIG. 6C.

Once self-expanding device (600) has been crimped, storage member (614)may be advanced along crimping member (606) to at least partially holdself-expanding device (600) in its reduced configuration, as shown inFIG. 6D. Crimping member (600) and/or a combination of first (608)and/or second (610) handles may then be disengaged from theself-expanding device (600), but they need not be. Additionally, pusher(612) may be used to eject self-expanding device (600) from storagemember (614) into an applicator or other device, or to ejectself-expanding device (600) at a target location.

In other methods, the crimped self-expanding device may be transferreddirectly into an applicator or other device. In variations in which thecrimping device includes an applicator guide, the applicator guide maybe used to position the storage member, applicator, or device relativeto the self-expanding device. It should be appreciated that any of thedevices as described above may include any suitable combination offeatures described herein and may be used to reduce a self-expandingdevice to an unexpanded configuration.

FIGS. 27A-27C show another variation of crimping device (2700)comprising cylinder (2702) defining aperture (2704), suture (2706) withhandle (2708), and crimping members (2710) comprising holding bars(2712), loops (2714) and eyelets (2716). In some variations, crimpingmembers (2710) may be rotatably attached to cylinder (2702), but neednot be. Additionally, crimping members (2710) may bend at loops (2714)to define space (2718) in which a self-expanding device (not shown) maybe placed, as shown in FIG. 27A. In some variations, suture (2706) maybe threaded through one or more eyelets (2716). In these variations,handle (2708) may be pulled away from cylinder (2702) to close crimpingmembers (2710) around the self-expanding device, as shown in FIG. 27B.This may hold the self-expanding device within crimping device (2700),and may additionally begin crimping the self-expanding member. Pullinghandle (2708) further away from cylinder (2702) may cause the holdingbars (2712) to straighten at loops (2714). This may in turn furthercrimp the self-expanding device. In some variations, this crimping maycause the self-expanding device to exit cylinder (2702) via aperture(2704). In other variations, the crimped self-expanding device may beremoved via aperture (2704).

While shown in FIGS. 27A-27C as having loops (2714), holding bars (2712)need not. Indeed, holding bars (2712) may have hinges or joints, or maybe made from a flexible material that is capable of straightening when acertain force is applied to it. Furthermore, in variations in which theholding bars (2712) have loops, hinges, or joints, they may have anynumber or combination of loops, hinges, and joints. Furthermore, whileshown as being attached to cylinder (2702), holding bars (2712) may beattached to any suitable structure having any suitable size and shape.

FIGS. 28A-28D show another variation of crimping device (2800),comprising base (2802), rim (2804), handle (2806) and a plurality ofcrimping members (2808). Crimping members (2808) may be attached to base(2802), and base (2802) may in turn be attached to rim (2804) and handle(2806). Generally, base (2802) may be able to move between an openposition, as shown in a perspective view in FIG. 28A, and a closedposition, as shown in a perspective view in FIG. 28B. In somevariations, handle (2806) may be used to move base (2802) between openand closed positions. In other variations, when the base (2802) is in anopen position, crimping members (2808) are directed outward, definingspace (2810). When the base (2802) is moved into the closed position,crimping members (2808) may rotate inward, decreasing the size of space(2810). To crimp a self-expanding device using crimping device (2800),self-expanding device may be placed in space (2810) when the base (2802)is in an open position, as shown in a side view in FIG. 28C. When handle(2806) moves base (2802) into a closed position, crimping members (2808)may engage self-expanding device to crimp self-expanding device to anunexpanded configuration, as shown in a side view in FIG. 28D.

In some variations, crimping devices may comprise one or more crimpingmembers that have one or more jaws. FIGS. 29A-29E show variations ofcrimping members comprising one or more jaws. More specifically, FIG.29A shows one variation of crimping device (2900) comprising crimpingmember (2902) in an open position and having base portion (2904) andalternating jaws (2906). In these variations, crimping member (2902) maydefine a space (2908), and may be configured to change to a closedposition in which alternating jaws (2906) move past each other to reducethe size of space (2908), as shown in FIG. 29B. In some variations,crimping member (2902) may be made of a material that has a naturaltendency to move the crimping member (2904) to a closed position. Inother variations, the crimping member (2902) may close in response to anexternal force. While shown in FIGS. 29A and 29B as being a singlecomponent, crimping member (2902) may be made of two or more components.For example, FIG. 29C shows one such variation of crimping member (2910)comprising hinged portions (2912), each having alternating jaws (2914)and handles (2916).

To crimp a self-expanding device (not shown) using crimping device(2900), the self-expanding device may be placed within space (2908) whencrimping member (2902) is an open position. When the crimping member(2902) moves to a closed position, alternating jaws (2906) and baseportion (2904) may engage the self-expanding device to crimp theself-expanding device to an unexpanded configuration. In somevariations, the self-expanding device may be crimped from a storagestructure. FIG. 29D shows one variation of storage structure (2918)comprising holder (2920), base (2922) and separator (2924). Generally, aself-expanding device (not shown) may be placed around holder (2920) andstored in an expanded configuration. A crimping device may then beplaced around storage structure (2918). FIG. 29E shows the crimpingmember (2910) of FIG. 29C placed around the storage structure (2918) ofFIG. 29D. Although shown in FIGS. 29D and 29E as having separator(2924), storage structure (2918) need not. In variations that do includea separator (2924), the separator (2924) may serve to hold thealternating jaws (2914) apart. The storage device (2918) may be pulledthrough crimping member (2910) to leave the self-expanding device withincrimping member (2910). In some variations, crimping member (2910) maycomprise a lip (not shown) or some other structure configured to ensurethat the self-expanding device remains within crimping member (2910). Asthis point, the crimping member (2910) may change from an open positionto a closed position in order to crimp the self-expanding device asdescribed above.

In some variations, the crimping devices include a holding structure andone or more crimping members. In these variations, the holding structureis generally configured to hold a self-expanding device in an expandedconfiguration, although it is noted that in other configurations theholding structure may be generally configured to hold the self-expandingdevice in an un-expanded configuration. One or more crimping members maythen engage the self-expanding device to reduce the self-expandingdevice to an unexpanded configuration. The self-expanding device mayeither be crimped directly into a storage member, applicator, or otherdevice, or may be transferred following crimping to a storage member,applicator, or other device.

FIGS. 7A-7D illustrate one such variation of crimping device (700),comprising crimping member (702) and holding structure (704). As shownin FIGS. 7A-7D, holding structure (700) includes passage units (706),shaping portion (708), and grips (710). Also shown there isself-expanding device (712). FIG. 7A shows a perspective view and FIG.7C shows a top view of crimping device (700) holding self-expandingdevice (712) in an expanded configuration. Crimping member (702) maythen engage self-expanding device (712) to reduce self-expanding device(712) to an unexpanded configuration, as shown in a perspective view inFIG. 7B and in a top view in FIG. 7D.

While shown in FIGS. 7A-7D as being a hoop, holding structure (704) maybe any suitable structure. Examples of suitable holding structuresinclude, but are not limited to, hoops, canisters, cages, rods, andplates defining one or more apertures. The holding structures may bemade of one or more separate pieces. Furthermore, the holding structuresmay have any suitable dimensions, shapes, or configurations. Forexample, while the hoop shown in FIGS. 7A-7D has a generally circularshape, the holding structure may define any suitable shape. Indeed, theholding structure may have an irregular shape or one that approximatesan oval, a triangle, a rectangle, a polygon or the like. This shape maybe determined by or may be based on the shape of the self-expandingdevice in its expanded configuration, but need not be. In somevariations, the size and/or shape of the holding structure may beadjusted or adjustable to accept self-expanding devices of differentsizes. Furthermore, although the hoop in FIGS. 7A-7D is shown as havinga height less than that of the self-expanding device, the holdingstructure may have any suitable height. In some variations, the holdingstructure has a larger height than the height of the self-expandingdevice. In still other variations, the height of the holding structuremay vary throughout the crimping device. In addition, the holdingstructure may include one or more additional features to help maintainthe self-expanding device in a desired configuration (whether expandedor un-expanded), e.g., rings (stationary or slidable), wires, ribbons,hoops, sheaths (stationary or slidable), pushers, and the like.

Furthermore, these crimping devices may include any suitable crimpingmember or combination of crimping members as described above. Thecrimping members may also contain any feature or combination of featuresas described above. While shown in FIGS. 7A-7D as having one crimpingmember, the crimping device may incorporate any number of crimpingmembers. Indeed, the crimping device may contain two or more crimpingmembers. For example, in some variations the crimping device may containtwo sutures encased within a sheath, similar to the crimping membersshown in FIG. 3. In other variations, the crimping device may contain aplurality of crimping members, wherein each crimping member has a hookthat may be used to engage the self-expanding device.

The crimping device may have any number of handles. These handles mayhave any shape or configuration as described above, and may be attachedto any, all, or none of the crimping members. Furthermore, the holdingstructure may have one or more handles or grips. These handles or gripsmay have any suitable shape or configuration.

As described hereinthroughout, the crimping device may engage aself-expanding device in a number of different ways. This engagement maydepend on the shape, structure, or configuration of the self-expandingdevice. In some variations, the crimping member may wrap around theself-expanding device and sit between the self-expanding device and theholding structure, as illustrated by crimping device (700) shown inFIGS. 7A-7D. In other variations, one or more crimping members may bewound around one or more portions of the self-expanding device. Invariations in which one or more of the crimping members include hooks orrings, the hooks or rings may be attached or affixed to theself-expanding device. In variations in which the self-expanding devicehas one or more loops, one or more crimping devices may be threadedthrough all, some, or none of the loops. In variations in which one ormore of the crimping members are balloons or pushers, the crimpingmember may push against the outer surface of the self-expanding device.

Furthermore, the crimping members may engage a holding structure in anumber of ways. In some variations, one or more ends of one or morecrimping members are attached to the holding structure. In othervariations, one or more ends of one or more crimping members passthrough the holding structure via one or more passage units. By moving aportion of a crimping member through a passage unit, a user may controlthe amount of engagement between the crimping member and aself-expanding device. This may, in turn, control the amount of crimpingof the self-expanding device. For example, in crimping device (700)shown in FIGS. 7C and 7D, pulling the ends of crimping member (702)through passage units (706) reduces the amount of crimping member (702)that resides within holding structure (700), which in turn causescrimping member (702) to pull against self-expanding device (712).

The passage units may be any suitable structure that is capable ofallowing at least a portion of a crimping member to pass through atleast a portion of a holding structure. Examples of suitable passageunits include, but are not limited to slits, slots, holes, grooves,contours, pulleys, and rollers. Passage units may have any suitableshape and dimension. In some variations, the size and shape of thepassage units may be determined by the dimensions of the crimpingmember. Additionally, passage units may be sized and shaped to acceptone or more portions of one or more crimping members. As such, when acrimping device contains passage units, each crimping member of thatcrimping device may pass through all, some, or none of the passageunits. For example, in some variations, such as the one shown in FIGS.7A & 7B, each end of a crimping member passes through a differentpassage unit. In other variations, both ends of a crimping member passthrough the same passage unit. In still other variations, one end of acrimping member is attached to the interior of the holding structure,and the other end passes through a passage unit.

In some instances, it may be desirable to limit the amount that aself-expanding device is crimped. Thus, the crimping device may includeone or more features that are designed to limit a device's crimping. Insome variations, one or more of the crimping members may contain avisual indicator. In these variations, one or more crimping members mayhave color-coded regions or other markers. In variations in whichcrimping occurs by pulling a crimping member through a holdingstructure, that crimping device may be configured such that whensufficient crimping has occurred, the visual indicator becomes visibleoutside of the holding structure, signaling the user to stop crimping.In variations in which crimping occurs by pushing a crimping member intoa holding structure, the crimping device may be configured such thatwhen sufficient crimping has occurred, the visual indicator ceases to bevisible outside of the holding structure.

In other variations, the crimping member may contain one or more stopsor other features that are unable to pass through a passage unit, andthus limit the ability of the crimping member to pass either into or outof the holding structure. The crimping member may be configured suchthat when the device has been sufficiently crimped, the stops engage thepassage unit and prevent any further crimping. Examples of suitablestops include studs, rings, and knots that are attached to a crimpingmember.

In other instances it may be desirable to prevent the self-expandingdevice from re-expanding once it has been reduced to an unexpandedconfiguration. Thus, the crimping device may include one or morefeatures that allow a crimping member to pass through the hoop in onedirection, but not the other direction. In some variations, one or morecrimping members may have such a feature. Indeed, FIGS. 30A-30C showvariations of crimping members having direction-limiting features. FIG.30A shows one variation crimping member (3000) comprising flaring flaps(3002). Crimping member (3000) may comprise any number of flaring flaps(3002), and these flaring flaps (3002) may be disposed along any portionor portions of crimping member (3000). FIG. 30B shows another variationof crimping member (3004) comprising a tapered stud (3006). Crimpingmember (3004) may comprise any number of tapered studs (3006), and thesetapered studs (3006) may be disposed along any portion or portions ofcrimping member (3004). FIG. 30C shows still another variation ofcrimping member (3008) comprising coil (3010). Coil (3010) may resistmovement through a passage unit (not shown), but may temporarily deformand pass through a passage unit if pushed or pulled with enough force.On the other side of the passage unit, coil (3010) may return to itsoriginal shape, resisting a return trip through the passage unit. Thecoil (3010) and passage unit may be configured such that anoperator-provided force is sufficient to move coil (3010) through apassage unit, but any restorative force provided by a crimpedself-expanding device is insufficient to return the coil through thepassage unit. Examples of suitable coil materials include, but are notlimited to, shape memory materials such as nickel-titanium alloys. Itshould be appreciated that a crimping member may include any combinationof flaring flaps, tapered studs, coils, and other features that allowfor unidirectional passage of a crimping member through a passage unit.

In other variations, the passage unit may contain one or more featuresfor allowing unidirectional movement of a crimping member therethrough.For example, the passage unit may contain semi-rigid flaps. FIG. 31shows one such variation of holding structure (3100) comprising passageunit (3102) having flaps (3104). Also shown there is crimping member(3106) comprising studs (3108). While shown in FIG. 31 as being angledoutward, flaps (3104) need not be. Additionally, while shown in FIG. 31as having studs (3108), crimping member (3106) may comprise ribs orother protrusions configured to pass through the flaps when the crimpingmember is pulled or pushed by a user and resist the restorative forceprovided by the crimped self-expanding device. In variations in whichthe passage unit contains rollers or pulleys, the rollers or pulleys maybe configured to rotate in only one direction. FIG. 32 shows one suchvariation of holding structure (3200) comprising rollers (3202). Alsoshown there is crimping member (3204). In these variations, when acrimping member (3204) is pulled through holding structure (3200) usingrollers (3202), rollers (3202) rotate in the direction indicated byarrows (3206). When crimping member (3204) is no longer being pulled,rollers (3202) hold crimping member (3204) in place against anyrestorative forces provided by a self-expanding device (not shown).Similarly, rollers (3202) may be configured to allow a crimping member(3204) to be pushed or pulled into holding structure (3200) and resistmovement out of the holding structure (3200).

In still other variations, the crimping device may include a clamping orclasping structure configured to hold one or more crimping members inplace relative to the holding structure. This clamping structure may beunable to pass through a passage unit in the holding structure, and maybe attachable to a crimping member. In these variations, the clampingstructure may be attached to a portion of a crimping member that hasjust passed through a passage unit, thereby preventing that portion fromreturning back through the passage unit. The clamping structure may beconfigured to reversibly attach to the crimping member, such that thecrimping member may be later released. FIG. 33 show one such variationof crimping device (3300) comprising holding structure (3302) withpassage unit (3304), crimping member (3306), and clamp (3308). Clamp(3308) may be attached to crimping member (3304) to prevent it frombeing pulled back through passage unit (3304), as shown in FIG. 33.Clamp (3308) may then be removed from crimping member (3304), therebyfreeing crimping member (3304) to pass through passage unit (3304).

The holding structure may define one or more apertures through which acrimped self-expanding device may be retrieved. FIG. 8 shows one suchvariation of holding structure (800) comprising canister (802) havingpassage structures (802) and defining aperture (804). Although shown inFIG. 8 as being located near one edge of holding structure (800),aperture (804) may be located anywhere in the holding structure (800).Indeed, in some variations the aperture may be located at the center ofthe holding structure. Furthermore, aperture may define anycross-sectional opening of any suitable shape. Examples of suitableshapes include, but are not limited to, circles, ovals, triangles,rectangles, other polygons, or shapes with irregular geometry. In someinstances, this shape may be dependent on the self-expanding device orthe storage member, applicator, or other device that may be used toretrieve the crimped self-expanding device.

Additionally, the holding structure may comprise one or more tracks.FIG. 9 illustrates one variation of holding structure (900) comprisingcanister (902) having passage units (904) and defining aperture (906)and tracks (908). Tracks (908) may serve multiple functions in theoperation of the crimping devices described here. In some variations,portions of a self-expanding device may pass at least partially throughone or more tracks. As the self-expanding device is reduced into anunexpanded configuration, the tracks may help guide the self-expandingdevice along a certain path or pattern during crimping. In othervariations, the crimping device includes one or more pins or bars. Insome of these variations, the pins may be slidably disposed within oneor more tracks in a holding structure, and the tracks may control thepath of movement of the pins through the tracks. These pins may be usedto aid in crimping a self-expanding device.

Tracks (908) may be located anywhere on or in holding structure (900).Although shown in FIG. 9 as being contiguous with aperture (906), tracks(908) may be non-contiguous with aperture (906). In some variations,some of tracks (908) may be contiguous with aperture (906) while othertracks (908) may be non-contiguous with aperture (906). In variations ofcrimping devices that include pins, as described below, having tracksseparate from an aperture may assist in preventing the pins from exitinga holding structure through that aperture. Additionally, while shown inFIG. 9 as being straight, tracks (908) need not be. Indeed, tracks maybe curved, zigzagging, or may not follow a set pattern. The tracks mayhave a constant width or may have a varying width.

FIGS. 10A-10C illustrate one variation of crimping device (1000). Shownin FIG. 10A is a perspective view of crimping device (1000) comprisingcrimping member (1002), pins (1004), and holding structure (1006) havingpassage unit (1008) and defining aperture (1010) and tracks (1012). Inthis variation, pins (1004) are slidably disposed within tracks (1012).FIG. 10B shows a cutaway view of holding structure (1006). As shown inFIG. 10B, crimping member (1002) is wrapped around pins (1004). One endof crimping member (1002) exits holding structure (1006) via passageunit (1008) while the other end of crimping member (1002) is attached toone of the pins (1004). As the end of crimping member (1002) is pulledthrough passage unit (1008), the pins (1004) are pulled by crimpingmember (1002) toward the center of holding structure (1006), as shown inFIG. 10C. As the pins (1004) move toward the center of holding structure(1006), the pins may cooperate with crimping member (1002) to crimp aself-expanding device (not shown) placed inside holding structure(1006).

The crimping device may also include one or more crimping controls thatare configured such that movement of crimping control relative to aholding structure causes the crimping device to reduce theself-expanding device to an unexpanded configuration. Examples ofsuitable crimping controls include, but are not limited to, ribbonpulls, cranks, winders and knobs. FIG. 11 shows one such example ofcrimping device (1100) comprising crimping member (1102), crimpingcontrol (1104), pins (1106), and holding structure (1108) definingaperture (1110) and tracks (1112). In FIG. 11, crimping control (1104)is a ribbon pull (1114). Generally, ribbon pull (1114) may be able torotate around the body of holding structure (1108), and may engagecrimping member (1102). In some variations, such as that shown in FIG.11, the ribbon pull (1114) is at least partially disposed within a track(1112) defined by the holding structure (1112). Generally, when ribbonpull (1114) rotates around the body of holding structure (1108),crimping member (1102) is pulled around pins (1106) causing the pins toslide along tracks (1112), as shown in FIGS. 10B and 10C.

FIGS. 12A-12D show another variation of crimping device (1200)comprising crimping control (1202), pins (1204), and holding structure(1206) defining aperture (1208) and tracks (1210). FIG. 12A shows aperspective view of crimping control (1200) comprising plate (1212) withcrimping tracks (1214). When crimping device (1200) is assembled, pins(1204) may be slidably disposed in both tracks (1210) of holdingstructure (1206) and crimping tracks (1214) of crimping control (1202),as shown in FIG. 12B. Generally, tracks (1210) of holding structure(1206) and crimping tracks (1214) of crimping control (1202) areconfigured such that rotation of the crimping control (1202) relative toholding structure (1206) causes the pins (1204) to slide in tracks(1210) and crimping tracks (1214). For example, as shown in FIGS.12A-12D, tracks (1210) of holding structure (1206) may radiate away fromaperture (1208) in straight lines, while crimping tracks (1214) ofcrimping control (1202) may radiate away from aperture (1208) in curvedlines. FIGS. 12C & 12D show bottom views of pins (1204) disposed withintracks (1210) and crimping tracks (1214). Pins (1204) may fit withinsections of overlap between tracks (1210) and crimping tracks (1214),and as the sections of overlap move, so do the pins (1204). As pins(1204) are moved closer together, as shown in FIG. 12D, the pins (1204)may crimp a self-expanding device (not shown).

FIGS. 34A-34C illustrate another variation of crimping device (3400)comprising holding structure (3402) having slots (3404) and casing(3406). Also shown there is crimping control (3408) comprising winder(3410) having handle (3412) and threading (3414). In these variations,holding structure (3402) may be a hoop capable of assuming differentshapes. FIG. 34A shows a perspective view of crimping device (3400).FIG. 34B shows a side view of winder (3410) of crimping device (3400),and FIG. 34C shows a side view of a portion of the holding structure(3402) of crimping device (3400). Generally, a portion of winder (3410)may be configured to be placed and held within casing (3406).Additionally, a portion of holding structure (3402) may pass throughcasing (3406), and the slots (3404) of holding structure (3402) mayengage threading (3414). As winder (3410) is rotated relative to holdingstructure (3402), this engagement may cause a portion of holdingstructure (3402) to pass through casing (3406), thereby either reducingor increasing the size of the space (3416) defined by holding structure(3402). If a self-expanding device (not shown) is placed within space(3416), rotation of winder (3410) may cause holding structure (3402) tocrimp the self-expanding device.

The crimping device may contain a number of structures or features thatmay provide utility in crimping a self-expanding device. In somevariations, as shown in FIG. 13, crimping device (1300) includes aholding structure (1302) that has a shaping portion (1304). Shapingportion (1304) may help to hold a self-expanding device in a certainshape when in its unexpanded configuration. Although shown in FIG. 13 asbeing a half-circle, the shaping portion (1304) may be any suitableshape. Indeed, shaping portion (1304) may be rectangular or triangularin shape. In variations in which the holding structure (1302) containspassage units (not shown), one or more of the passage units may beplaced within shaping portion (1304), but need not be.

FIG. 14 shows one variation of crimping device (1400) comprising holdingstructure (1402) with shaping portion (1404) and applicator guides(1406) with passage units (1408). Applicator guides (1406) may serve anumber of purposes. In some instances, applicator guides (1406) may beused to guide a storage member, applicator or other device (not shown)into a position to either enclose or to receive a crimped self-expandingdevice (not shown). While shown in FIG. 14 as having two applicatorguides (1406), holding structure (1402) may have any number ofapplicator guides (1406). Additionally, while shown in FIG. 14 as havingpassage units (1408), applicator guides (1406) need not. Applicatorguides (1406) with passage units (1408) may find particular utility ininstances where a self-expanding device has a height greater than thatof the holding structure (1402). In some of these variations, theapplicator guide (1406) may function as a shaping portion, as describedabove.

FIG. 15 shows another variation of crimping device (1500) comprisingholding structure (1502) having protrusion (1504) and passage units(1506). Protrusion (1504) may serve to provide a space between holdingstructure (1502) and a self-expanding device (not shown). This space mayallow a storage member, applicator, or other device to surround acrimped self-expanding device without pushing downward on theself-expanding device. Alternatively, such a space may be provided by anindentation or gap in a wall of the holding structure.

FIG. 16 shows yet another variation of crimping device (1600) comprisingholding structure (1602) having an ejector (1604). Ejector (1604) may beused to push a crimped self-expanding device out of crimping device(1600). In some variations, the ejector (1604) may push a crimpedself-expanding device from crimping device (1600) into a storage member,an applicator, or other device (not shown). Ejector (1604) may be of anysuitable shape, size, or configuration. In some variations, such asshown in FIG. 16, ejector (1604) may operate via pressure placed on abaseplate (1606) of pusher (1608). In other variations, the ejector maybe spring-loaded or may be trigger-activated.

FIG. 17 shows still another variation of crimping device (1700)comprising holding structure (1702) having applicator guide (1704),movable portion (1706), cutting device (1708) and passage units (1710).Cutting device (1708) may be any suitable cutting structure and may beused to sever crimping members (not shown), thereby freeing aself-expanding device (not shown) from holding structure (1702). Whileshown in FIG. 17 as having one cutting device (1708), crimping device(1700) may have any number of cutting devices (1708). Indeed, crimpingdevice (1700) may have two or more cutting devices (1708) or no cuttingdevice (1708) at all. Additionally, while shown in FIG. 17 as having amovable portion (1706), crimping device (1700) need not. In variationsthat do include a movable portion (1706), the movable portion may movecutting portion (1708) to sever one or more crimping members. In somevariations, movable portion (1706) may move in response to pressureapplied by a storage member, applicator, or other device. The downwardmovement of movable portion (1706) in response to pressure by anapplicator may also serve to further guide the applicator around acrimped self-expanding device. In some variations, the movable portion(1706) may be configured to return to its original position whenpressure is no longer being applied by an applicator. It should also beappreciated that the crimping devices described here may have anysuitable combination of crimping members, holding structures, applicatorguides, passage units, shaping portions, cutting devices, movableportions, protrusions and ejectors.

To crimp a self-expanding device using a crimping device comprising oneor more crimping members and a holding structure, a self-expandingdevice is generally placed within the holding structure and one or moreof the crimping members engage the self-expanding device. The one ormore crimping members may engage self-expanding device in any suitablemanner as described above. In methods where the crimping device includesone or more pushers, one or more of the pushers may be pushed throughthe holding structure to crimp the self-expanding device. In methods inwhich the crimping device includes one or more crimping members in theform of sutures, wires, guiding hoops, or ribbons, one or more ends ofends of the one or crimping members may be pulled through the holdingstructure via a passage unit to crimp a self-expanding device. Inmethods in which the crimping device includes one or more balloons, oneor more of the one or more balloons may be inflated to compress theself-expanding device.

Once the self-expanding device has been crimped to an unexpandedconfiguration, the self-expanding device may be transferred to a storagedevice, an applicator, or other device. In some methods, an ejector isused to push the self-expanding device into an applicator. In othermethods, the applicator removes the self-expanding device from thecrimping device. In some methods, the self-expanding device is pushed orpulled through the crimping members. In other methods, the crimpingmembers are severed by a blade. In still other methods, the crimpingmembers may be disengaged from either the self-expanding device or thecrimping device as the self-expanding device is placed within anapplicator.

In some variations of crimping devices described here, the crimpingdevices include some combination of crimping portions, storage zones,and applicator engagement portions. FIGS. 18A & 18B show one variationof crimping device (1800) comprising crimping portion (1802), storagezone (1804), and applicator engagement portion (1806). FIG. 18A shows aperspective view of crimping device (1800), while FIG. 18B shows acutaway view of crimping device (1800).

Generally, crimping portion serves to reduce an expandable member froman expanded configuration to an unexpanded configuration. While shown inFIGS. 18A and 18B as being a funnel with a frustoconical shape, crimpingportion (1802) may have any suitable shape or configuration. In somevariations, the crimping portion (1802) may have a shape that hasirregular geometry or that approximates an oval, triangle, rectangle,polygon, or the like. The crimping portion may additionally include aholding portion configured to hold a self-expanding device in anexpanded configuration. In some variations, the crimping portion (1802)may include one or more slits. In variations that include slits, theseslits may serve to guide portions of a self-expanding device as it iscrimped. Additionally, slits may allow for a pronged-pusher to beadvanced through crimping portion (1802), as will be described in moredetail below.

While shown in FIGS. 18A & 18B as having a storage zone (1804), thecrimping device need not. In variations that do include a storage zone,the storage zone may be configured to house a self-expanding device inits unexpanded configuration. Storage zone (1804) may have any suitableshape or configuration. In some variations, such as that shown in FIGS.18A & 18B, storage zone may be a cylinder. In other variations, storagezone may be a box, cone, pyramid or curved tube. The storage zone may bedetachable from the rest of the crimping device, but need not be. Insome variations, storage zone may include one or more blades or cuttingmembers. In other variations, storage zone may include a lip that isconfigured to allow a self-expanding a device to be pushed through astorage zone in one direction, but resists movement by theself-expanding device in the opposite direction.

While shown in FIGS. 18A and 18B as having an applicator engagementportion (1806), the crimping device (1800) need not. In variations thatdo include an applicator engagement portion (1806), the applicatorengagement portion may have any suitable configuration. Generally,applicator engagement portion (1806) is configured to allow crimpingdevice (1800) to temporarily or permanently attach to an applicator,storage member, or other device. In some of these variations, asillustrated in FIGS. 18A and 18B, applicator engagement portion (1806)is an inlet into which an applicator may be placed. In some of thesevariations, the end of applicator engagement portion (1806) may flareoutward. Alternatively, the applicator engagement portion (1806) may beconfigured to fit within an applicator.

The crimping device (1800) may additionally include one or more pullers,pushers or other structures for moving a self-expanding device throughat least a portion of the crimping device. FIGS. 19A and 19B show sideviews of one variation of crimping device (1900) having holding portion(1902), crimping portion (1904), storage zone (1906) and puller (1908).Also shown there is self-expanding device (1910). Initially,self-expanding device (1910) may be held in holding portion (1902), asshown in FIG. 19A. Puller (1908) may engage self-expanding device (1910)to draw self-expanding device through crimping portion (1904). Asself-expanding device (1910) moves through crimping portion (1904),self-expanding device (1910) may be reduced from an expandedconfiguration to an unexpanded configuration. In variations in which thecrimping device (1900) includes a storage zone (1906), puller (1908) maydraw self-expanding device (1910) into storage zone, as shown in FIG.19B. In these variations, the puller (1908) may then be disengaged fromself-expanding device (1910), or may be used to draw self-expandingdevice into a separate storage member, applicator, or other device. Invariations in which the crimping device (1900) does not include astorage zone (1906), puller may draw self-expanding device (1910)directly into a storage member, applicator, or other device.

While shown in FIGS. 19A and 19B as having a handle (1912), sutures(1914), and rings (1916), puller (1908) may have any suitableconfiguration. In some variations, puller (1908) may include more thanone handle. In some variations, one or more of the one or more handlesare sized to fit through crimping device (1900). Puller (1908) mayadditionally include one or more sutures, wires, ribbons, orcombinations thereof. In some of these variations, the sutures, wires,or ribbons may include one or more hooks or rings configured forattachment to a self-expanding device. Puller (1908) may engageself-expanding device in any suitable manner as described above.

FIGS. 20A and 20B show another variation of crimping device (2000),comprising holding portion (2002), crimping portion (2004), storage zone(2006), and balloon (2008). Also shown there is self-expanding device(2010). As shown in FIG. 20A, balloon (2008) may be inflated inside ofcrimping device (2000) while self-expanding device (2010) is held withinholding portion (2002). Inflation of balloon (2008) may cause balloon(2008) to engage self-expanding device (2010). Balloon (2008) may bewithdrawn through crimping device (2000), which in turn may pullself-expanding device (2010) through crimping portion (2004) and intostorage zone (2006). Balloon (2008) may be partially deflated as it iswithdrawn through crimping device (2000). Balloon (2008) mayadditionally be used to pull self-expanding device (2010) into a storagemember, applicator, or other device. Alternatively, balloon (2008) maybe deflated and removed once self-expanding device (2010) has reachedstorage zone (2006).

FIGS. 21A and 21B show still another variation of crimping device(2100), comprising holding portion (2102), crimping portion (2104),storage zone (2106) and pusher (2108). Also shown there isself-expanding device (2110). Initially, self-expanding device (2110)may be held in holding portion (2102), as shown in FIG. 21A. Pusher(2108) may engage self-expanding device (2110) to push self-expandingdevice (2110) through crimping portion (2104). As self-expanding device(2110) moves through crimping portion (2104), self-expanding device(2110) may be reduced from an expanded configuration to an unexpandedconfiguration. In variations in which the crimping device (2100)includes a storage zone (2106), pusher (2108) may press self-expandingdevice (2110) into storage zone (2106), as shown in FIG. 21B. In thesevariations, the pusher (2108) may then be disengaged from self-expandingdevice (2110), or may alternatively push self-expanding (2110) deviceinto a separate storage member, applicator, or other device. Invariations in which the crimping device (2100) does not include astorage zone (2106), pusher (2108) may push self-expanding device (2110)directly into a separate storage member, applicator, or other device.

While shown in FIGS. 21A and 21B as having handle (2112) and semi-rigidwires (2114), pusher (2108) may have any suitable configuration ofcomponents. In some variations, pusher (2108) may include more than onehandle. Pusher (2108) may additionally include one or more rods, wires,plugs, or combinations thereof. In some of these variations, rods,wires, or plugs may include one or more heads or rings configured forattachment to a self-expanding device. In some variations, pusher (2108)is made of a sponge or similar compressible material that is capable ofconforming to the interior of crimping portion (2104). Pusher (2108) mayengage self-expanding device in any suitable manner as described above.

FIGS. 22A and 22B show a variation of crimping device (2200) comprisingstorage zone (2204), crimping portion (2206) with slits (2208), andpusher (2210) with prongs (2212). Initially, a self-expanding device(not shown) may be placed in crimping device (2200). Pusher (2210) maybe moved through crimping portion (2206), and one or more of the prongs(2212) may engage one or more of slits (2208) to guide as shown in FIG.22B. Pusher (2210) may also engage the self-expanding device. As pusher(2210) is advanced through crimping portion (2206), slits (2208) mayguide and control the advancement of pusher (2210). Simultaneouslypusher (2210) may also move a self-expanding device through crimpingportion (2206), thereby crimping the self-expanding device. Slits (2208)may additionally serve to help guide self-expanding device throughcrimping portion (2206) as the self-expanding device is crimped. In somevariations, the pusher may be a slotted funnel. FIG. 35A shows one suchvariation of crimping device (3500) comprising crimping portion (3502)with slots (3504) and aperture (3506), and pusher (3508) with slots(3510), prongs (3512), and aperture (3514). The pusher (3508) may engagecrimping portion (3502) to crimp a self-expanding device (not shown), asdescribe above. While shown in FIG. 35A as having five prongs (3512) andfive slots (3510), pusher (3508) may have any suitable number of slots(3510) and prongs (3512). For example, FIG. 35B shows a side view of onevariation of crimping device (3514) comprising crimping portion (3516)with slots (3518), and pusher (3520) with many slots (3522) and prongs(3524).

Crimping device (2200) may include any number of slits (2208), and slits(2208) may be of any size, shape or configuration. While shown in FIGS.22A and 22B as extending along the entire length of crimping portion(2206), slits (2208) need not. Indeed, in some variations, slits (2208)may extend only along a portion of crimping portion (2206). In othervariations, slits (2208) may extend past crimping portion (2206) andinto at least a portion of storage zone (2204).

Any of the features of the crimping devices described here may beautomated. For example, in some variations the crimping device comprisesa trigger, a button, a combination thereof, or the like. In some ofthese variations, a trigger or button may be configured to control oneor more features a device. For example, activation of a trigger orbutton may cause a pusher to push a self-expanding member through acrimping portion, or may cause a crimping member to pass through apassage unit. Indeed, triggers or buttons may be used to automate anyfeature or combination of features described here.

Some variations of the crimping devices described here comprise one ormore plates that are engagable to define an aperture. FIGS. 23A and 23Billustrate one variation of crimping device (2300) comprising first(2302) and second (2304) plates that are engaged to define aperture(2306). In some variations, first (2302) and second (2304) plates may beslidably engagable.

Aperture (2306) may define a cross-sectional opening of any size orshape. Indeed, aperture (2306) may be a shape that has irregulargeometry or that approximates a diamond, oval, circle, triangle,rectangle, polygon, or the like. Furthermore, aperture (2306) may besymmetrical, but need not be. In variations in which aperture (2306) issymmetrical, it may be symmetrical along any number of axes. Indeed,aperture (2306) may be symmetrical along zero, one, or two axes. Invariations where the first (2302) and second (2304) plates are slidablyengaged, aperture (2306) may change in size or shape as first (2302) andsecond (2304) plates are slid relative to each other. For example, asshown in FIG. 23A, aperture (2306) has a shape that approximates arounded diamond. As first (2302) and second (2304) plates are slidrelative to each other, as shown in FIG. 23B, aperture (2306)approximates a circular shape.

While shown in FIGS. 23A and 23B as having two plates, crimping device(2300) may have any number of plates. Indeed, in some variations, thecrimping device may have three or more plates. FIGS. 24A and 24B showone such variation of crimping device (2400) having first (2402), second(2404), and third plates (2406). Also shown there are holding portions(2408). In variations where crimping device (2400) includes three ormore plates, each plate may be slidably engagable with all, some, ornone of the remaining plates. Furthermore, each plate may be fixedlyattached to all, some, or none of the remaining plates.

In variations of crimping device (2400) that include three or moreplates, each plate may define an aperture with any other plate. Thus,crimping member (2400) may define two or more apertures. Each of theseapertures may have the same size and shape, but they need not. Indeed,in some variations different apertures may have different sizes ordifferent shapes. As such, variations of crimping device (2400) thatinclude three or more plates may find particular utility in situationsin which non-uniform crimping of a self-expanding device is desirable.

Additionally, crimping device (2400) may include one or more featuresthat may aid in the crimping of a self-expanding device. In somevariations, crimping device (2400) may include spacers located betweenall, some, or none of the plates. In other variations, crimping device(2400) may include one or more handles that may aid in handling oroperating crimping device (2400). In still other variations, such as thevariations shown in FIGS. 24A and 24B, crimping device (2400) mayinclude one or more extenders (2408). Generally, extenders (2408) mayhelp to hold portions of a self-expanding device (not shown) that is notengaged by the plates. In some variations, multiple extenders (2408) mayinteract to completely enclose a self-expanding device as the apertureor apertures defined by the plates is reduced, as shown in FIG. 24B.Additionally, extenders (2408) may engage a storage member, applicator,or other device to facilitate retrieval of the self-expanding device.Extenders may also act to hold a crimped self-expanding device in acertain shape.

While shown in FIGS. 24A and 24B as being located on first (2402),second (2404), and third (2406) plates, extenders may be affixed to orformed on any number of plates. Indeed, extenders may be placed on all,some, or none of the plates. Similarly, each plate may include anynumber of extenders. For example, in the variation shown in FIG. 24A,first (2402) and third plates (2406) each have one extender (2408),while second plate (2404) has two extenders (2408).

Generally, the crimping devices described above may be used to crimp aself-expanding device to a reduced configuration. In these methods, theself-expanding may be placed in one or more apertures defined by thecrimping device. As some or all of the plates are moved, one or more ofthe one or more apertures may change shape and/or size. As the size ofthe aperture is decreased the self-expanding device becomes crimped. Thecrimped self-expanding device may then be placed in a storage member,applicator, or other device.

Some variations of the crimping devices described here include one ormore crimping tubes. FIGS. 36A-36F show one variation of crimping device(3600) comprising top plate (3602) having funnel (3604), bottom plate(3606), and crimping tube (3608). Generally, crimping tube (3608) may beattached between top (3602) and bottom (3606) plates, as shown in aperspective view in FIG. 36A and in a cutaway view in FIG. 36B. Crimpingtube (3608) may be made from or comprise any suitable flexible material,such as, for example, latex. When top plate (3602) is rotated relativeto bottom plate (3606), crimping tube (3608) may wrap around itself,reducing the diameter of crimping tube (3608) and bringing top (3602)and bottom (3606) plates closer together, as seen in FIG. 36C.

Crimping device (3600) may be used to crimp a self-expanding device(3610). Generally, self-expanding device (3610) may be placed withincrimping tube (3608), as shown in FIG. 36D. When top plate (3602) andbottom plate (3606) are rotated relative to each other, crimping tube(3608) may reduce in diameter to engage and crimp self-expanding device(3610), as shown in FIG. 36E. Once the self-expanding device (3610) iscrimped, the self-expanding device (3610) may be ejected from crimpingdevice (3600) through funnel (3604) by pushing top (3602) and bottom(3606) plates together.

In some variations, a crimping device comprising a crimping tube mayadditionally comprise a holding structure. FIGS. 37A-37E show onevariation of crimping device (3700) comprising top plate (3702)including funnel (3704), bottom plate (3706), crimping tube (3708),cylinder (3710) having threading (3712), and holding structure (3714)having prongs (3716) and pusher (3718). Also shown there isself-expanding device (3720). Generally, crimping tube (3708) may beattached between top (3702) and bottom (3704) plates, as shown in FIG.37A. Additionally, prongs (3716) and pusher (3718) may be able to passthrough corresponding slots (not shown) in bottom plate (3706).

To crimp a self-expanding device (3720) using crimping device (3700),holding structure (3714) may be inserted into bottom plate (3706) suchthat prongs (3716) and pusher (3718) extend through the correspondingslots in bottom plate (3706). A self-expanding device (3720) may then beplaced around prongs (3716), and stored in an expanded configurationinside of crimping tube (3708), as shown in FIG. 37B. When theself-expanding device (3720) is ready to be crimped, holding structure(3714) may be withdrawn from bottom plate (3706), which may in turnleave self-expanding device within crimping tube (3708), as shown inFIG. 37C. Top plate (3702) may be rotated relative to bottom plate(3706), thereby reducing the diameter of crimping tube (3708) andcrimping self-expanding device (3720), as shown in FIG. 37D. Thisrotation may be guided by grooves (not shown) in top plate (3702) thatengage threading (3712) of cylinder (3710). Once the self-expandingdevice (3720) has been crimped, it may be ejected or removed fromcrimping device (3700). In some variations, the self-expanding device(3720) is ejected from crimping device (3700) by reinserting holdingstructure (3714) into bottom plate (3706) such that pusher (3718)engages self-expanding device (3720) to push it through funnel (3704) oftop plate (3702).

While shown in FIGS. 37A-37E as having prongs (3716) and pusher (3718),holding structure (3714) may have any configuration. In some variations,holding structure (3714) may have prongs (3716) but no pusher (3718). Insome variations, crimping device (3700) has a pusher (3718) that isseparate from holding structure (3714). In variations that includeprongs (3716), holding structure (3714) may comprise any number ofprongs (3716). Indeed, holding structure may have zero, one, or two ormore prongs (3716). Furthermore, these prongs may be sized and shaped tohold a self-expanding device (3720) in an expanded configuration. Insome variations, the configuration of prongs (3716) may be determined byor based upon the size and shape of the self-expanding device (3720) inan expanded configuration. In other variations, the prongs (3716) may beconfigured to hold a self-expanding device (3720) in a certain shape.

Additionally, while shown in FIGS. 37A-37E as having a cylinder (3710)with threading (3712), crimping device (3700) need not. In variationsthat do include a cylinder (3710), cylinder (3710) may help to keepbottom plate (3706) positioned relative to top plate (3702).Additionally, threading (3712) may limit the amount of rotation thatoccurs between top plate (3702) and bottom plate (3706).

In some variations, a crimping device comprising a crimping tube mayadditionally comprise guide cylinders. FIGS. 38A-38F show one variationof crimping device (3800) comprising top plate (3802) having slots(3804), funnel (3806) and top guide cylinder (3808) with protrusions(3810), crimping tube (3812), and bottom plate (3814) having slots(3804), funnel (3806), and bottom guide cylinder (3816) withindentations (3818). Also shown there is holding structure (3820) withprongs (3822). FIG. 38B shows a perspective view of crimping device(3800), while FIG. 38A shows a perspective view of crimping device(3800) without crimping tube (3812). In some variations, crimping tubemay be attached between top plate (3802) and bottom plate (3814).Furthermore, protrusions (3810) of top guide cylinder (3808) areconfigured to engage indentations (3818) of bottom guide cylinder (3816)to allow top guide cylinder (3808) to slide within bottom guide cylinder(3816). Additionally, prongs (3822) of holding structure (3820) may beable to pass through corresponding slots (3804) on either top (3802) orbottom (3814) plates.

To crimp a self-expanding device (not shown) using crimping device(3800), holding structure (3820) may be inserted into bottom plate(3814) such that prongs (3822) extend through the corresponding slots(3804) in bottom plate (3814), as shown in FIG. 38C. In some variations,holding structure (3820) may be instead be inserted into top plate(3802). A self-expanding device may then be placed around prongs (3822)and stored in an expanded configuration inside of crimping tube (3812).When the self-expanding device is ready to be crimped, holding structure(3820) may be withdrawn from bottom plate (3816), as shown in FIG. 38D.This may in turn leave self-expanding device within crimping tube(3812). Top plate (3802) may be rotated relative to bottom plate (3814),as shown in FIG. 38E. This may reduce the diameter of crimping tube(3812), crimp the self-expanding device, and align protrusions (3810)and indentations (3818). Once protrusions (3810) and indentations (3818)are aligned, top (3802) and bottom (3814) plates may be pushed together,causing top guide cylinder (3808) to slide within bottom guide cylinder(3816), as shown in FIG. 38F. In some variations, the self-expandingdevice may then be ejected from crimping device (3800) through funnel(3804) of either top (3802) or bottom (3814) plates using a pusher orother ejector.

Top (3808) and bottom (3816) guide cylinders may have any suitablenumber of indentations (3818) and protrusions (3810). Furthermore, theseindentations (3818) and protrusions (3810) may have any suitable shapeand size. Different protrusions (3810) may have the same size and shape,or may have different sizes or shapes. Similarly, different indentations(3818) may have the same size and shape, or may have different sizes orshape. In some variations, each protrusion (3810) may be configured tobe able to engage only one indentation (3818). In other variations, eachprotrusion (3810) may be configured to be able to engage two or moreindentations (3818).

While the crimping devices described above have generally beenconfigured to crimp one self-expanding device, any of the crimpingdevices described above may also be configured to crimp any number ofself-expanding devices. In some variations, two or more self-expandingdevices may be crimped sequentially. In some of these variations, thesame crimping device is reusable to crimp any number of self-expandingdevices. In other variations, two or more self-expanding device may becrimped simultaneously. Additionally, the two or more crimpedself-expanding devices may be transferred into the same storage member,applicator or other device, or may be transferred into two or morestorage members, applicators, or other devices. In some variations, thecrimping devices may have one crimping member that engages multipleself-expanding devices to crimp the self-expanding devices. In othervariations, the crimping devices may have a plurality of crimpingmembers, where each crimping member engages one or more self-expandingdevices to crimp the one or more self-expanding devices.

FIG. 39 illustrates one variation of crimping device (3900) that may becapable of crimping multiple self expanding devices (not shown). Shownthere are crimping members (3902) and holding structures (3904) havingpassage units (3906). In some variations, each holding structure (3904)may be configured to crimp one or more self-expanding device. Whileshown in FIG. 39 as having three holding structures (3904), crimpingdevice (3900) may have any suitable number of holding structures (3904).Additionally, each holding structure (3904), passage unit (3906), andcrimping member (3902) may have any suitable configuration orcombination of features as described above.

FIG. 40 shows another variation of crimping device (4000) that may becapable of crimping multiple self-expanding devices (not shown). Shownthere is holding structure (4002) with passage units (4004) and crimpingmembers (4006) having sheath (4008) and handle (4010). In thesevariations, sheath (4008) may be sized to hold two or moreself-expanding devices. When the crimping members (4006) are pulledthrough passage units (4004), the sheath (4008) may engage the two ormore self-expanding devices. This engagement may crimp the two or moreself-expanding devices simultaneously.

Also described here are kits. These kits may comprise any suitablecomponents. For example, the kits may comprise one or moreself-expanding device, and one or more of the crimping devices describedabove. The kits may also comprise instructions for using any of the kitcomponents, or assembling any of the kit components. In some variations,the kits include separate, unassembled components of the crimpingdevice. In some of these variations, the kit may also include one ormore tools to help with assembly of the crimping device. In somevariations, the kits may include one or more storage members,applicators, or other devices. In other variations, the kits may includeone or more storage structures for storing one or more self-expandingdevice in an expanded configuration.

What we claim is:
 1. A crimping device for crimping a self-expandingdevice having an unexpanded configuration and an expanded configuration,the crimping device comprising: a holding structure, the holdingstructure comprising a hoop configured to hold therein theself-expanding device in its expanded configuration, the hoop comprisingat least one passage unit; and a crimping member positioned in theholding structure, wherein a first end portion of the crimping memberextends through the at least one passage unit, wherein movement of thefirst end portion of the crimping member through the at least onepassage unit reduces the amount of crimping member in the holdingstructure and causes the crimping device to reduce the self-expandingdevice to its unexpanded configuration.
 2. The crimping device of claim1, wherein the self-expanding device is biodegradable.
 3. The crimpingdevice of claim 1, wherein the crimping member comprises a ribbon. 4.The crimping device of claim 1, wherein the passage unit comprises aslot.
 5. The crimping device of claim 1, wherein a second end portion ofthe crimping member remains in the interior of the holding structureduring movement of the first end portion through the at least onepassage unit.
 6. The crimping device of claim 1, wherein the crimpingmember is configured to wrap around the self-expanding device and sitbetween the self-expanding device and the holding structure.
 7. Thecrimping device of claim 1, wherein the holding structure comprises atleast two separate components that together form the holding structure.8. The crimping device of claim 1, wherein the holding structure definesan aperture through which the self-expanding device may be retrievedwhen the self-expanding device is in its unexpanded configuration.